Rectal drain appliance

ABSTRACT

A rectal drainage appliance is disclosed comprising a tubular element having an inflatable balloon at a distal end for anchoring the appliance in the rectum. The appliance includes one or more of: (i) first and second auxiliary lumens communicating with the inflatable balloon to provide independent inflation and pressure monitoring paths coupled to the balloon; (ii) a pressure state indicator defined by a mechanical element configured to flip between first and second states or shapes responsive to sensed pressure; and (iii) a collapsible auxiliary lumen larger than the inflation lumen, and configured to permit admission of irrigation fluid. The pressure state indicator may also be used in intestinal drains.

CROSS-REFERENCE

This application is a continuation of application of U.S. patentapplication Ser. No. 12/990,229, filed on Oct. 29, 2010, which is a U.S.National Phase of PCT/US09/42544, filed May 1, 2009, which claims thebenefit of U.S. Provisional Application No. 61/049,578, filed on May 1,2008, each of which is entirely incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to a rectal appliance in the form of adrain tube having an inflatable balloon insertable into the rectum inuse. Another aspect of the invention relates to a pressure levelindicator for indicating the pressure level within the inflatableballoon(s) of a rectal or intestinal drain.

BACKGROUND TO THE INVENTION

U.S. Patent Publication Nos. 2005/054996 and 2005/137526 describe fecalmanagement appliances in the form of elongate tubular elements. Eachtubular element includes an inflatable balloon at the distal end, foranchoring the distal end in an operative position in the wearer'srectum. The tubular element includes a main drain passage, and twosmall-size auxiliary lumens, similar to each other and integrated intothe wall of the drain passage. One of the lumens communicates with theballoon for passing inflation fluid between the balloon and an inflationport during inflation and deflation. The other of the lumens has an openend for injecting irrigation fluid from an irrigation port directly intothe rectal cavity. The tubular element is collapsible in diameter, tofacilitate passage through the anal sphincter. US-A-2005/054996 inparticular emphasizes the significance of controlling carefully theinflation pressure in the balloon, to provide good anchoring in therectum, while still ensuring normal blood perfusion in the soft tissuecontacted by the balloon, and avoiding pressure necrosis of the softtissue. In one form, pressure level indicators are used on the inflationlumen to provide a clinician with important indication of pressure. Thepressure level indicators include a separate pressure sensor coupled tothe inflation lumen near the inflation port, or a pressure indicatorintegrated in an inflation syringe, or spring loading the inflationsyringe to act as a pressure stabilizer and indicator. The point atwhich a desired inflation pressure is reached, with respect to thevolume of inflation fluid used, is also an important characteristic usedby the clinician to assess whether the balloon is a correct size for arectal cavity of the wearer. If an inflation pressure threshold isreached too quickly, this indicates that the balloon is too large; if aninflation pressure is never reached, this indicates that the balloon istoo small.

Although not described explicitly in the above published applications,there are also several constraints affecting the size of the auxiliarylumens in the designs illustrated in these applications. Whereas themain tubular element is intended to be collapsible in diameter tofacilitate passage through the anal sphincter, the auxiliary lumens havea small non-collapsing form to permit application of suction forforcibly withdrawing inflation fluid from the balloon when it is desiredto deflate the balloon down to a minimum size. The non-collapsing natureof the lumens means that the lumens obstruct collapsing of the maintubular element. The auxiliary lumens are relatively small to minimizethis obstructing effect, and enable the main tubular element to collapseto a desirably small form.

U.S. Patent Publication No. 2008/0312614 describes an ileostomy set usedfor drainage and collection of fluid/feces from the small intestine.This set includes a balloon catheter equipped with two balloons, afixation balloon which is inflated in the large intestine and a blockingballoon which is inflated in the small intestine behind the Bauhinvalve. Each of the balloons fills the entire lumen in which it isplaced. The point at which a desired inflation pressure is reached ineach of the balloons, with respect to the volume of inflation fluidused, is an important characteristic to assess whether each balloon is acorrect size for the large and small intestine of the patient.

It would be desirable to further enhance the versatility and ease of useof such rectal drain appliances.

SUMMARY OF THE INVENTION

One aspect of the invention provides a pressure level indicator for theinflatable balloon(s) of a rectal drainage catheter or an intestinaldrain. The pressure level indicator includes a mechanical element thatflips between first and second distinct physical states depending onsensed pressure. The states may be different shapes of the element. Themechanical element may have a three-dimensional shape, such as a domeshape, that flips between a non-inverted state, and an inverted state.In one state, the dome projects like a popped-up button; in the otherstate, the dome is depressed like a valley or well. The mechanicalelement may form an integrally molded part of a plastics housing. Theprovision of a mechanical element that flips its state can provide aninstantly recognizable and unambiguous indication of a certain pressurestate, and can also be easier and quicker for a clinician to assess thanhaving to read off a measurement value from a variable scale of apressure sensor. The mechanical element may also be more compact, and/ormore lightweight, and/or less expensive to provide, than a conventionalvariable pressure sensor. The pressure level indicator of this aspect ofthe invention may be integrated as part of a disposable appliance,without any significant increase in cost. For example, the pressurelevel indicator may be integrated into an inflation port housing of theappliance.

The mechanical element may flip from the first state to the second statewhen the sensed pressure crosses (exceeds or drops below) a thresholdwith respect to external pressure acting on the element. The mechanicalelement may be configured to flip back to the first state should thesensed pressure re-cross the threshold in the opposite direction, sothat the element always provides an indication of the current pressurestate. Alternatively, the mechanical element may remain permanently inthe second state to provide a permanent record that the pressurethreshold was crossed.

Multiple mechanical elements may be provided that flip at differentpressure thresholds. For example, two mechanical elements may beprovided to show whether the inflation pressure is in a desiredinflation range. Additionally, or alternatively, a first mechanicalelement may indicate that a desired inflation pressure has been attainedfor achieving desired anchoring of the appliance in the rectum, and asecond mechanical element may indicate that a desired deflation pressurehas been attained for allowing easy and safe removal of the appliancefrom the rectum.

Another aspect of the invention provides a rectal drainage appliancecomprising an inflatable balloon for insertion into the rectum. Theappliance comprises first and second auxiliary lumens communicating withthe inflatable balloon. The first auxiliary lumen is used as aninflation lumen. The second auxiliary lumen is used as a pressuresensing lumen for providing a direct indication of inflation pressure inthe balloon, independent of dynamic pressure drop in the inflationlumen.

This aspect of the invention arises from an appreciation that a smallsized inflation lumen can impose a resistance to flow of inflationfluid, and create a dynamic pressure drop while there is a flow ofinflation fluid into the balloon during inflation, or out of the balloonduring deflation. The dynamic pressure drop means that a measurement ofpressure at the inflation port might not be an accurate indication ofpressure in the balloon at all times. The provision of a secondauxiliary lumen provides direct sensing of the internal pressure in theballoon, and enables a clinician to have an accurate indication of thisinternal pressure unaffected by any dynamic pressure drop in theinflation lumen.

In a preferred form, at least the second lumen is prefilled withinflation fluid. This minimizes the pressure drop between the balloonand the mechanical element as the second lumen fills with inflationfluid.

Another aspect of the present invention provides a tubular element of arectal drain appliance, the tubular element having a main drain passage,at least one non-collapsing (or non-collapsible) auxiliary lumen, and atleast one collapsing (or collapsible) auxiliary lumen. The collapsingauxiliary lumen preferably has a larger cross-sectional area than thenon-collapsing auxiliary lumen, at least when the collapsing auxiliarylumen is in a distended shape. The non-collapsing auxiliary lumen maycommunicate with an inflatable balloon provided at a distal end of thetubular element. The collapsing auxiliary lumen may communicate directlyor indirectly with an open space at the distal end of the tubularelement.

This aspect of the invention arises from an appreciation that, althoughan auxiliary lumen associated with an inflatable balloon is beneficiallynon-collapsing to allow the application of suction, there is lessconstraint for an auxiliary lumen for irrigation. The third aspect ofthe invention enables a relatively large auxiliary lumen for injectingirrigation fluid. As well as making irrigation easier, the lumen mayalso be used in more versatile ways, for example, allowing the insertionof a temperature sensor or other medical device into the rectal cavity,without interfering substantially with drainage. When the supply ofirrigation fluid, or the medical device, is removed from that lumen, thelumen can collapse to a small size, so that the provision of the largeauxiliary lumen does not obstruct the desired collapsing property of thetubular element.

Viewed in another aspect, the invention provides a rectal drainageappliance comprising a tubular element having an inflatable balloon at adistal end for anchoring the appliance in the rectum. The applianceincludes one or more of: (i) first and second auxiliary lumenscommunicating with the inflatable balloon to provide independentinflation and pressure monitoring paths coupled to the balloon; (ii) apressure state indicator defined by a mechanical element configured toflip between first and second states or shapes responsive to sensedpressure; and (iii) a collapsible auxiliary lumen larger than theinflation lumen, and configured to permit admission of irrigation fluidor a medical device via the collapsible lumen to the distal end of theappliance.

An additional aspect of the invention is a pressure indicator orinflation port configured to act as an inflation fluid admission andwithdrawal point for controlling the inflation state for each of theinflatable balloons of an intestinal drain of the type shown in U.S.Patent Publication No. 2008/0312614.

The above aspects may be used in combination, or any two of the aboveaspects may be selectively combined together, or any aspect may be usedindependently of the others. While features believed to be of importancehave been emphasized above and in the following claims and description,the Applicant may seek to claim protection for any novel feature of ideadisclosed herein and/or illustrated in the drawings whether or notemphasis has been placed thereon.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic sectional view showing a first embodiment of arectal drainage appliance.

FIG. 2 is a schematic cross-sectional view along the line II-II of FIG.1.

FIG. 3 is a schematic perspective view showing in isolation the pressureindicator or inflation port of the first embodiment or an intestinaldrain including an integrated pressure sensor.

FIG. 4(a) is a schematic sectional view illustrating a firstconfiguration of molded mechanical element for the pressureindicator/inflation port.

FIG. 4(b) illustrates a flipped state of the first configuration ofmolded mechanical element for the pressure indicator/inflation port.

FIG. 5(a) is a schematic sectional view illustrating a secondconfiguration of molded mechanical element for the pressureindicator/inflation port.

FIG. 5(b) illustrates a flipped state of the second configuration ofmolded element for the pressure indicator/inflation port.

FIG. 6 is a schematic perspective view showing an alternative pressureindicator in a second embodiment of the pressure indicator/inflationport, including multiple state indicators.

FIG. 7 is a schematic view of an alternative pressureindicator/inflation port in a third embodiment of the invention.

FIG. 8 is a schematic partial view of a fourth embodiment of a rectaldrainage appliance.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The same reference numerals denote similar or equivalent features ineach embodiment. Additional constructional details for rectal drainagetubes may be found in the aforementioned U.S. Patent Publication Nos.2005/054996 and 2005/137526, the contents of which are incorporatedherein by reference.

Referring to FIGS. 1 and 2, a rectal drainage appliance 10 generallycomprises a flexible elongate tubular element 12 defining a drainchannel 14 for passage of stool. The element 12 has a distal end 16 forinsertion through the anus into the rectum of a wearer, and a proximalend 18 for coupling to a fecal collector (not shown) such as a pouch.Typically, element 12 is about 1.5 m long, and has an outer diameter ofabout 23 mm. The element 12 can collapse down to about 8 mm in diameterto facilitate passage through the anal sphincter. The element 12 istypically made of soft plastics, such as silicone. The element 12 may beprovided with an additional odor barrier layer, or a separate odorbarrier sleeve (not shown), to obstruct transpiration of malodorsthrough the wall of the drain channel 14.

An inflatable balloon 20 is provided at the distal end 16, for anchoringthe distal end 16 inside the rectum. The inflatable balloon 20 isgenerally cuff or toroid shaped, and extends around the distal end 16.The inflatable balloon 20 may be configured of material that stretcheselastically as the balloon 20 inflates, but it is preferred that theballoon 20 be pre-formed in an inflated shape. Such pre-forming enablesthe inflation pressure to be reduced in use, because there is little orno elastic return force in the balloon wall acting against desiredinflation.

The tubular element 12 comprises first and second auxiliary lumens 22,24 that both communicate with the balloon 20. The lumens 22, 24 may beof about the same size (e.g., cross-section area) or the second lumen 24may be smaller than the first lumen 22. One of the lumens 22, 24, forexample the first lumen 22, is used as an inflation lumen for passinginflation fluid between the balloon 20 and an inflation port 26, forinflating or deflating the balloon 20 when desired. The other lumen, forexample the second lumen 24, is used as a pressure sense lumen forproviding a direct indication of pressure inside the balloon 20,independent of any dynamic pressure drop in the inflation lumen 22, asexplained below.

The first and second auxiliary lumens 22, 24 are configured to besubstantially non-collapsing in use, in order to allow the applicationof suction for forcibly withdrawing inflation fluid and deflating theballoon 20 completely down to a minimum size. This applies for bothelastic and pre-formed types of balloon, but is especially important forthe pre-formed type because there is no elastic return force in theballoon wall tending to act to expel inflation fluid. In order to avoidthe non-collapsing auxiliary lumens 22, 24 from compromising desiredcollapsing of the element 12 overall, the first and second lumens 22, 24are relatively small in size (e.g., a diameter of about 2 mm or less).Such a small diameter size can impose a resistance to substantial volumeflow of inflation fluid in the lumen 22, 24, thereby causing a dynamicpressure drop in the inflation lumen 22 during inflation or deflation ofthe balloon 20. The dynamic pressure drop creates a difference betweenthe fluid pressure P_(B) within the balloon 20, and the fluid pressureP_(IP) seen at the inflation port end of the inflation lumen 22. Thiscan make pressure measurements taken from the inflation lumen 22inaccurate, or at least ambiguous, during inflation or deflation untilfluid flow has stopped. However, the provision of an additional pressuresense lumen 24 in the present embodiment enables direct sensing of fluidpressure P_(B) within the balloon 20, using a path that is significantlyless affected by dynamic pressure drop resulting from volume flow in theinflation lumen 22. Since the pressure sensing apparatus will generallynot itself cause significant volume flow, the sensed pressure P_(S) atthe proximal end of the sensing lumen 24 is a much more accurate,stable, unambiguous and continuous representation of the fluid pressureP_(B) within the balloon 20 throughout inflation and deflationprocesses. Moreover, since the both auxiliary lumens 22, 24 havenon-collapsing walls, the auxiliary lumen 24 also allows accuratesensing of low pressure in the balloon 20 as a result of application ofsuction to deflate the balloon 20. This enables a clinician to observethe inflation pressure reliably, and also the point at which theinflation pressures reaches a certain level for assessing whether theballoon size is in fact suitable for the wearer. At least the secondauxiliary lumen 24 may be pre-filled with inflation fluid to allowimmediate use, without requiring any air to be expelled, or additionalfilling of inflation fluid to ready appliance before use.

In the present embodiment, the first and second auxiliary lumens 22, 24are grouped together into a common extrusion 30. The extrusion 30 has agenerally figure-of-8, or “B” shape. The first and second auxiliarylumens 22, 24 may be independent lumens within, or outside, the tubularelement 12, but in the preferred form at least one (and preferably both)of the lumens 22, 24 are attached to, or integrally molded with, thetubular element 12 along a significant portion of the auxiliary lumenlength.

Also in the present embodiment, the sensing lumen 24 leads to the samehousing 32 as that containing or carrying the inflation port 26. Thehousing 32 further comprises or carries first and second nodes 33coupled to the auxiliary lumens 22, 24. In one form, the housing 32 maycomprise or carry an additional pressure sensing port (not shown) forallowing connection of an external pressure sensor (not shown) formonitoring the sensed pressure via the sensing lumen 24. However, in thepreferred form, the housing 32 includes an integral pressure indicator34 responsive to the pressure sensed via the sensing lumen 24.

Referring to FIGS. 3-5, the pressure (or pressure state) indicator 34comprises a mechanical element 36 that flips between first and seconddistinct physical states (e.g., shapes) depending on the sensedpressure. In the illustrated form, the mechanical element 36 has aninverting three-dimensional shape, such as a dome shape, the inverted ornon-inverted state of which indicates the pressure level state. In onestate, the dome projects like a popped-up button; in the other state,the dome is depressed like a valley or well. The mechanical element 36is an integrally molded part of the housing 32. The mechanical element36 may flip from the first state to the second state when the sensedpressure crosses (exceeds or drops below) a pressure threshold withrespect to external pressure acting on the element. FIG. 4(a) shows afirst configuration of mechanical element 36 molded in a first depressedstate, and FIG. 4b ) shows the mechanical element 36 of the firstconfiguration flipping to a second projecting state when the pressure P+behind the element 36 exceeds ambient external pressure by a certainthreshold. FIG. 5(a) shows an alternative second configuration ofmechanical element 36 molded in a first projecting state, and FIG. 45(b)shows the mechanical element 36 of the second configuration flipping toa second depressed state when the pressure P− behind the element dropsbelow ambient external pressure by a certain threshold.

The pressure (differential) at which the mechanical element 36 flips maybe set by design of the material properties, the geometry of thethree-dimensional shape, and the thickness and resilience of the element36. Additionally, an auxiliary reinforcing member (not shown) may beused to reinforce the element 36 and provide additional control. Themechanical element 36 may be configured to flip back to the first stateshould the sensed pressure re-cross the threshold in the oppositedirection, so that the element 36 always provides an indication of thecurrent pressure state. Alternatively, the mechanical element 36 may beconfigured to remain permanently in the second state, thereby providinga permanent record that the pressure threshold was crossed.

As best seen in FIG. 3, during manufacture, the housing 32 is moldedwith an internal cavity with a temporary opening 38 on one side in whicha mold core is received for molding the interior shape of the mechanicalelement 36. In order to complete the housing 32, the temporary opening38 is later plugged or sealed closed (for example, by welding oradhesive).

The use of mechanical element 36 to indicate pressure by flippingbetween distinct states (e.g., shapes) can provide an instantlyrecognizable and unambiguous indication of a certain pressure state, andcan also be easier and quicker for a clinician to assess than having toread off a measurement value from a variable scale of a pressure sensor.The mechanical element 36 may enable the pressure indicator 34 to be anyof more compact, more lightweight, and/or less expensive than aconventional variable pressure sensor. The pressure indicator 34 is thussuitable to be included as an integral part of a disposable rectaldrainage appliance 10. The pressure (or pressure state) indicator 34having mechanical element 36 may also be used in an intestinal drainageor drain appliance device having an inflatable balloon, see, e.g., U.S.Patent Publication No. 2008/0312614.

In the embodiment of FIGS. 1-5, the pressure indicator 34 includes asingle mechanical element 36 that is configured to represent a singlepressure state, such as a predetermined inflation pressure level havingbeen reached (using the first configuration of FIGS. 4(a) and 4(b)). Thesecond embodiment illustrated in FIG. 6 provides two or more mechanicalelements 36 a, 36 b, etc. each configured to indicate a respectivedifferent pressure state. For example, first and second mechanicalelements 36 a, 36 b may be provided to show whether the inflationpressure is in a desired inflation range, the lower limit of which isindicated using one mechanical element 36 a, and the upper level ofwhich is indicated by the other mechanical element 36 b. Both mechanicalelements 36 a and 36 b may be of the first configuration (FIGS. 4(a) and4(b)). This can enable the clinician to determine whether the inflationpressure is within an optimum operative range, even if the range isrelatively narrow. Additionally, or alternatively, the first mechanicalelement 36 a may indicate that a desired inflation pressure has beenattained for achieving desired anchoring of the appliance in the rectum,and a further mechanical element (e.g., 36 b or 36 c) may indicate thata desired deflation or suction pressure has been attained in the balloon20, ensuring that the balloon 20 is in its fully collapsed form allowingeasy and safe removal of the appliance 10 from the rectum. This furtherelement may be of the second configuration (FIGS. 5(a) and 5(b)).

Referring again to FIGS. 1 and 2, the tubular element 12 furthercomprises a collapsing auxiliary lumen 50. The collapsing lumen 50 has across-sectional area (when in a distended state indicated in phantom)larger than that of each of the first and second non-collapsing lumens22, 24. In one form, the collapsing lumen 50 has a distendedcross-sectional diameter of between about 2 mm and 5 mm. The collapsinglumen 50 communicates directly or indirectly with the opening at thedistal end 16 of the tubular element 12. In use, the collapsing lumen 50permits easy injection of irrigating fluid into the rectal cavity viathe lumen 50. The large size of the lumen 50 allows easier flow ofirrigation fluid at a lower pressure than does, for example, arelatively small size irrigation lumen used in the prior art. The largesize of the lumen 50 also permits easy insertion of a medical device(for example, a temperature sensor) into the rectal cavity, which mightnot be possible, at least not as easily practicable, using therelatively small auxiliary lumen of the prior art. When the source ofirrigation fluid, or the medical device, is removed, the lumen 50 cancollapse down to its compact state. Either the wall of the lumen 50 isresilient to collapse the lumen 50 with a resilient return force to itscompact state, or the wall of the lumen 50 is flexible to permitcollapsing when the lumen 50 is compressed. Therefore, the provision oflumen 50 does not compromise the desired collapsing of the tubularelement 12, nor does it obstruct substantially drainage of effluent viathe drain channel 14 within the tubular element 12 when the lumen 50 isin its normal collapsed or compact state.

It will be appreciated that any of the ideas of (i) the collapsing lumen50, (ii) the dual lumens 22, 24 communicating with the inflatableballoon 20, and (iii) the pressure indicator 34, may be used selectivelyin combination with, or independently of, any of the other ideas.However, greater synergy results as more of the ideas are combined.

Referring to FIG. 7, a pressure indicator 60 is shown similar to thepressure indicator 34 described previously, except that the pressureindicator 60 does not communicate with a dedicated sense lumen, andinstead is responsive to the inflation pressure in the inflation lumen22. The pressure indicator 60 is integrated into the housing 32, andcommunicates directly with the port 26 and the lumen 22. This embodimentmay be useful to implementing an alternative pressure indicator forexisting designs of tubular element without a dedicated sense lumenindependent of the inflation lumen 22, such as the appliances describedin the aforementioned U.S. Patent Publication Nos. 2005/054996 and2005/137526.

Referring to FIG. 8, a fourth embodiment is illustrated implementing thecollapsing auxiliary lumen 50 communicating with the distal end 16, andthe dual non-collapsing lumens 22, 24 communicating with the balloon 20.An alternative pressure sensor 70 is provided coupled to the sense lumen24. The pressure sensor 70 comprises a housing 72 containing a plunger74 biased by a spring 76. At least a portion of the housing 72 istransparent to permit viewing of the position of the plunger 74, whichposition is directly indicative of the balloon pressure sensed via thesense lumen 24.

The foregoing description illustrates preferred embodiments of theinvention. Many equivalents, modifications and improvements may be usedwithout departing from the scope of the invention as claimed.

I claim:
 1. An inflation port device for an appliance, the inflationport device being configured to act as an inflation fluid admission andwithdrawal point for controlling the inflation state of an inflatableballoon of the appliance, the inflation port device comprising: ahousing; an inflation port carried by the housing for permittingcoupling of an inflation source; and a pressure indicator carried by thehousing for indicating an inflation pressure level, the pressureindicator comprising a visually accessible first mechanical element,said visually accessible first mechanical element is configured to flipbetween first and second physical states depending on the inflationpressure crossing a first pressure threshold.
 2. The inflation portdevice of claim 1, wherein the inflation port comprises first and secondnodes for coupling to independent lumen paths communicating with theballoon of the appliance, the first node being coupled in the housing tothe inflation port, and the second node being coupled in the housing tothe pressure indicator.
 3. A rectal drain appliance comprising: atubular element defining a drain passage for effluent from the rectum;an inflatable balloon at a distal end of the tubular element forinsertion into the rectum; a first auxiliary lumen communicating withthe inflatable balloon for passing inflation fluid between the balloonand an inflation port, for permitting inflation and deflation of theballoon; and a second auxiliary lumen communicating with the inflatableballoon for direct sensing of pressure in the balloon independently ofdynamic pressure drop in the first lumen, wherein the direct sensing ofpressure in the balloon occurs at a proximal end of the rectal drainappliance.
 4. The rectal drain appliance of claim 3, wherein the tubularelement is configured to permit collapsing of the tubular element, andthe first and second auxiliary lumens are configured to benon-collapsing.
 5. The rectal drain appliance of claim 3, wherein eachof the first and second auxiliary lumens has a diameter of about 2 mm orless.
 6. The rectal drain appliance of claim 3, further comprising apressure indicator coupled to the second auxiliary lumen for indicatingpressure within the balloon.
 7. The rectal drainage appliance of claim6, wherein the pressure indicator is an integral part of the appliance.8. The rectal drainage appliance of claim 3, wherein the first andsecond lumens are disposed side-by-side in a common extrusion.
 9. Therectal drainage appliance of claim 3, wherein the first and secondlumens are attached to, or integrally molded with, the drainage passage.10. The rectal drainage appliance of claim 3, wherein at least one ofthe auxiliary lumens is pre-filled with inflation fluid.
 11. The rectalinflation port device of claim 1, wherein the inflation port devicecomprises a second mechanical element, said second mechanical element isconfigured to flip between first and second physical states depending onthe inflation pressure crossing a second pressure threshold that isdifferent from the first pressure threshold.